CirrhosisNCT03225677
Novel Tracer Methods to Evaluate Muscle Protein Metabolism in Cirrhosis
An observational study of Cirrhosis, run by The Cleveland Clinic at 1 site in United States.
Trial summary
To determine the rate and mechanisms of skeletal muscle protein synthesis and breakdown in cirrhotic patients by using multiple tracers and single muscle biopsies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis
- What is being tested?
- blood draw and muscle biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2017to 30 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Study population: Adults with the diagnosis of cirrhosis will be recruited from the hepatology inpatient service, outpatient clinics and liver transplant clinics at the Cleveland Clinic Foundation. The diagnosis of cirrhosis will be based on liver biopsy and/or clinical, biochemical, and imaging criteria. Will include patient with Child Pugh score from A5- to B7
Who may be able to join
- The diagnosis of cirrhosis based on liver biopsy and/or clinical, biochemical, and imaging criteria.
- Patients with Child Pugh score from A5- to B7
- Control group: Subject in control group should have serum ALT and AST within normal range.
- Exclusion Criteria for both groups (cirrhotic and control) are:
- diabetes
- cancer
Show all 11Show fewer
- kidney failure
- pregnancy
- recent surgery (bowel resection or Gastric bypass operation)
- Advanced cardiac or pulmonary disease
- patient with thyroid disease \& Coagulopathy ( INR >1.4 and platelet count <80,000/ml)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Annette Bellar, MSLA, 216-445-0688, bellara@ccf.org
About this study
Official title: Multiple Tracer Using Single Muscle Biopsy Technique in Evaluating Protein Synthesis and Break Down in Muscles of Cirrhotic Patients
To determine the rate and mechanisms of skeletal muscle protein synthesis and breakdown in cirrhotic patients by using multiple tracers and single muscle biopsies.
Read the detailed description
The goal of this study is to identify the molecular regulatory mechanisms that result in loss of skeletal muscle in cirrhotic patients. Current strategies involve prolonged tracer infusion and multiple muscle biopsies. We will use an innovative approach to determine the rates of skeletal muscle protein synthesis and breakdown using multiple tracers administered at short intervals followed by a single muscle biopsy. These studies are likely to provide a conceptual advance in determining the cellular and molecular responses of the skeletal muscle in cirrhosis.
- Conditions
- Cirrhosis
- Being tested
- blood draw and muscle biopsy
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood draw and muscle biopsyProcedure or surgery
One venous catheter will be used for bolus injection of multiple labeled AA at the beginning .The second venous catheter will inserted in the other arm for 5 ml of arterialized venous blood draw.Following the infusions, a single muscle biopsy will be performed from the vastus lateralis of the thigh using the Bergstromm needle.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Cirrhosis | Patients with a diagnosis of cirrhosis will have a blood draw and muscle biopsy will be performed. Receives: Procedure: blood draw and muscle biopsy | |
| controls | control group should have serum ALT and AST within normal range and a blood draw and muscle biopsy will be performed Receives: Procedure: blood draw and muscle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional Synthesis Rate
Fractional synthesis rate (FSR)for each patient is measured by the rate of tracer incorporation from the MIF pool to the bound pool.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start3 Aug 2017
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srinivasan Dasarathy, The Cleveland Clinic
- Investigators
- Srinivasan Dasarathy, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225677
- Sponsor's protocol ID
- 14-1476
- Status last verified
- Sep 2026
- First submitted
- 17 Apr 2017
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Tracer Using Single Muscle Biopsy Technique in Evaluating Protein Synthesis and Break Down in Muscles of Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT03225677
- Acronym / sponsor ID
- 14-1476
- Conditions
- Cirrhosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the rate and mechanisms of skeletal muscle protein synthesis and breakdown in cirrhotic patients by using multiple tracers and single muscle biopsies.
Detailed description
The goal of this study is to identify the molecular regulatory mechanisms that result in loss of skeletal muscle in cirrhotic patients. Current strategies involve prolonged tracer infusion and multiple muscle biopsies. We will use an innovative approach to determine the rates of skeletal muscle protein synthesis and breakdown using multiple tracers administered at short intervals followed by a single muscle biopsy. These studies are likely to provide a conceptual advance in determining the cellular and molecular responses of the skeletal muscle in cirrhosis.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Cirrhosis | – | Procedure: blood draw and muscle biopsyPatients with a diagnosis of cirrhosis will have a blood draw and muscle biopsy will be performed. |
| controls | – | Procedure: blood draw and muscle biopsycontrol group should have serum ALT and AST within normal range and a blood draw and muscle biopsy will be performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Study population: Adults with the diagnosis of cirrhosis will be recruited from the hepatology inpatient service, outpatient clinics and liver transplant clinics at the Cleveland Clinic Foundation. The diagnosis of cirrhosis will be based on liver biopsy and/or clinical, biochemical, and imaging criteria. Will include patient with Child Pugh score from A5- to B7
Key inclusion criteria (11 listed)
- The diagnosis of cirrhosis based on liver biopsy and/or clinical, biochemical, and imaging criteria.
- Patients with Child Pugh score from A5- to B7
- Control group: Subject in control group should have serum ALT and AST within normal range.
- diabetes
- cancer
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood draw and muscle biopsyOne venous catheter will be used for bolus injection of multiple labeled AA at the beginning .The second venous catheter will inserted in the other arm for 5 ml of arterialized venous blood draw.Following the infusions, a single muscle biopsy will be performed from the vastus lateralis of the thigh using the Bergstromm needle. | Procedure or surgery | Patients with Cirrhosis, controls |
Primary outcome
Fractional Synthesis Rate
Time frame: 4 hours
Fractional synthesis rate (FSR)for each patient is measured by the rate of tracer incorporation from the MIF pool to the bound pool.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Srinivasan Dasarathy, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annette Bellar, MSLA (2164450688, bellara@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional Synthesis Rate (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.